FDA product code JXS: Block, Cutting, Ent, Sterile
JXS is the FDA product code for block, cutting, ent, sterile. It is a Class I device, regulated under 21 CFR 874.3540 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 2 510(k) submissions under JXS, from 2 different applicants. The average 510(k) review took 56 days (median 56).
Classification
| Field | Value |
|---|---|
| Device name | Block, Cutting, Ent, Sterile |
| Device class | Class I |
| Regulation | 21 CFR 874.3540 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JXS clearance
Top JXS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Solarcare Technologies Corp,Inc. | 1 | 1995-04-14 |
| Treace Medical, Inc. | 1 | 1982-09-09 |
Most recent JXS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K950308 | Solarcare Technologies Corp,Inc. | STC DIAGNOSTICS AUTO-LYTE(R) METHAQUALONE EIA | 1995-04-14 | 79 |
| K822371 | Treace Medical, Inc. | MICRO WORKTABLE | 1982-09-09 | 34 |
Recalls for JXS devices
openFDA lists no recalls for product code JXS.
Frequently asked questions
What is FDA product code JXS?
JXS is the FDA product code for block, cutting, ent, sterile. It is a Class I device, regulated under 21 CFR 874.3540 and reviewed by the Ear, Nose and Throat panel.
What device class is JXS?
Class I, regulation 21 CFR 874.3540. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JXS?
Across 2 cleared submissions the average was 56 days from receipt to decision (median 56).
Which companies have the most JXS clearances?
Solarcare Technologies Corp,Inc. (1); Treace Medical, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JXS
- Run a recall and safety report across every JXS manufacturer
- Watch product code JXS for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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